EFFICACY TRIAL OF CALCIUM IN FRACTURE PREVENTION

Project Details

Description

DESCRIPTION: The purpose of thisapplication is to request funds for continuation of a prospective,randomized, double-blind, placebo-controlled study of the efficacy ofincreased calcium intake in the prevention of spine fractures and bone lossin elderly women. Funding for this study began in June of 1987 by theNational Dairy Promotion and Research Board and the National Dairy Counciland is committed until December 31, 1990. Application for renewal for1991-1993 was scheduled for submission in June 1990. The NDCadministrators have stated that there may not be sufficient funds tocontinue it and they have requested that funds be sought elsewhere forcompletion of the study. The hypothesis to be tested in the project isthat spine fractures and bone loss in elderly women with low calciumintakes can be reduced by adding 1200 mg.day of calcium as carbonate to thediet. The specific aims are: to continue a study of 223 women over theage of 60; to continue performing annual spine radiographs under standardconditions on each subject; to continue monitoring the clinical history ofappendicular fracture; to continue performing semiannual measurements ofbone mineral content of the forearm; to continue performing measurements ofserum levels of 25-hydroxy vitamin D on a subset of 50 subjects; and tocontinue administration of placebo or calcium, 1200 mg/day, as calcium ascarbonate to randomly chosen subjects in a double blind design, Theprinciple endpoints will be vertebral deformity by strictly definedmorphometric criteria and forearm bone mineral density. Appendicularfractures will be monitored and may also accumulate to a sufficient numberto become an endpoint.